BLG 699 Lecture Notes - Lecture 12: Council For International Organizations Of Medical Sciences, Clinical Trial, Informed Consent
Document Summary
Blg 699 wk 12 globalization and drug development. Pfizer sent physicians to kano, nigeria in the midst of a meningitis epidemic to test. After two weeks, they left and children died or suffered from disabilities from the. Pfizer failed to secure informed consent from children/guardian. Say that there was no regulation or law requiring ethical committee approval before conduction a clinical trial/study. No need to obtain what the law did not require. Patients already had serious symptoms of meningitis. This is one illustration of negative consequences of clinical testing in developing. Exact numbers are unknown, but clinical trials are increasingly conducted in low- countries income countries. Reflected in both: domestic state regulations and, guidelines published by international public and professional organizations. Guidelines issued by the council for international organization of medical sciences (cioms) Human protection from unnecessary risk: because of vulnerability, lack of autonomy, limited ability to understand and evaluate research themselves. Pediatric trials and guidelines potential for clinical benefit.
